Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors

Indiana University

Status: Completed

Conditions: Fear; Malignant Tumor of Breast; Cancer of Breast; Breast Cancer; Mammary Cancer; Mammary Neoplasms, Human; Mammary Carcinoma, Human; Human Mammary Carcinoma; Anxiety; Breast Neoplasm; Malignant Neoplasm of Breast; Breast Carcinoma

Treatments: Behavioral: Cognitive Behavioral Therapy; Behavioral: Acceptance Commitment Therapy; Behavioral: Enhanced Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05364450

11066

R01CA255480 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Fear of cancer recurrence (FCR) is a highly prevalent, disruptive, and under-treated problem for breast cancer survivors. This randomized controlled trial will test the efficacy of group-based Acceptance and Commitment Therapy compared to Cognitive Behavioral Therapy and enhanced usual care for breast cancer survivors suffering from FCR while examining its cost-effectiveness and the mechanisms by which the intervention may work. Study findings will guide the future care of breast cancer survivors with FCR.

Full description

The primary objective of this 3-arm randomized control trial (RCT) is to build on the investigators' pilot work by testing the impact of Acceptance Commitment Therapy (ACT) on FCR. The investigators will randomly assign up to 375 early-stage Breast Cancer Survivors (BCS; for at least 300 study completers after attrition) who have finished primary cancer treatment and who report clinically significant FCR to: (1) group-based ACT (6 weekly 1.5-hour videoconference sessions), (2) group-based Cognitive Behavioral Therapy (CBT; 6 weekly 1.5-hour videoconference sessions), or (3) Enhanced Usual Care (EUC; a single 90-minute videoconference coaching session with self-administered readings). Outcomes will be assessed at baseline and at 2, 6, and 12 months; additionally, potential theory-driven mediators of the ACT intervention's effects on key outcomes will be analyzed at these time points and at intervention midpoint. Cost-effectiveness of each intervention will be assessed.

Specific Aims are to: (1) test the efficacy of group-based ACT compared to CBT and EUC on FCR (primary outcome) and anxiety, depressive symptoms, post-traumatic stress, avoidant coping, fatigue, sleep disturbance, and quality of life (secondary outcomes) in BCS with clinical FCR; (2) to examine changes in psychological flexibility as a mediator of ACT's effect on FCR; and (3) to perform comparative assessments of ACT, CBT, and EUC to determine the cost-effective intervention.

Enrollment: 390 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is ≥18 years old.
• Patient has been diagnosed with stage I-IIIA breast cancer without evidence of distant disease at time of study entry.
• Patient has completed surgery, radiation therapy, chemotherapy, and/or biologic therapy ≤5 years prior (ongoing endocrine therapy is allowed).
• Patient has clinically significant FCR (FCR-7 score ≥17 at screening).
• Patient is willing to be randomized into any of the 3 arms of the trial and attend a 6-week videoconference group if randomly assigned to ACT or CBT and a single videoconference group if randomly assigned to EUC.
• Patient is able to speak and read English

Exclusion criteria

• Patient has a previous cancer diagnosis besides breast (non-melanoma skin cancer or melanoma in situ is allowed).
• Patient is currently participating in ACT, CBT, formal mindfulness meditation training, the "Mobile Device CBT for Chemotherapy-Related Cognitive Dysfunction: A Multi-Center Randomized Controlled Trial," the "Thinking and Living With Cancer" study, or any other research study that has the potential to skew results of this study or the study in which the person is participating.
• Patient has co-morbidities, medications, or deficits that would impair participation in any of the 3 groups (ACT, CBT or EUC), including: history of stroke, encephalitis, traumatic brain injury/surgery, Alzheimer's disease, or other dementia; severe depressive symptoms (PHQ-2 score ≥5 at screening); active substance abuse or uncontrolled bipolar disorder, psychosis, or schizophrenia; obvious hearing and/or communicative disability.
• Patient has opted out of pre-screening for research studies (sometimes noted in the electronic medical record)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

390 participants in 3 patient groups

Enhanced Usual Care (EUC)

Active Comparator group

Description:

The EUC group will meet for a single 90-minute coaching session via Zoom Health.

Treatment:

Behavioral: Enhanced Usual Care

Acceptance Commitment Therapy (ACT)

Active Comparator group

Description:

The ACT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.

Treatment:

Behavioral: Acceptance Commitment Therapy

Cognitive Behavioral Therapy (CBT)

Active Comparator group

Description:

The CBT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.

Treatment:

Behavioral: Cognitive Behavioral Therapy